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Tretin 0.05/0.025 gel is an example of a topical medication used for the treatment of mild to moderate cases of acne vulgaris in patients [1]. This topical medication contains Isotretinoin, which is an active ingredient indicated for the treatment of various acne forms in the skin. Isotretinoin is famous for its effectiveness in the treatment of worst cases of acne, but it does so in oral form. The topical Isotretinoin is “milder” and has a localized effect on its patients [2], as opposed to the systemic effect of the oral Isotretinoin products.

Isotretinoin gels are used for mild acne cases only as they only work on the surface of the skin by increasing the rate of the shredding of the old cells to make way for new ones [2]. By this action, the comedones are expelled and the skin’s renewal is initiated.

Tretin is made by the manufacturer PNG Gerolymatos Medical S.A. in Greece and the company makes the Isotretinoin gel in two forms, the 0.05% and the 0.025%. The company also makes Tretin capsules, which are oral Isotretinoin forms.

About PNG Gerolymatos Medical S.A.

PNG Gerolymatos Medical S.A. is one of the international pharmaceutical companies found in Greece [3]. The company specializes in the manufacture and development of health and beauty products for its local and international consumers [3]. Aside from making its own products, the company also is concerned with the distribution of the products of its global partners in the business [3].

PNG Gerolymatos Medical S.A. Main Office

The company’s nature of business can be classified into 4 fields. PNG Gerolymatos manufactures OTC medication, meds for Optics, veterinary medicines, and Logistics [3]. This company started in 1923 as a pharmacy and now has been 90 years in the business[4]. In 2008, the company has about 1,100 employees and its products already reached 50 of the world’s countries [4]. Its presence is recognizable in Europe, Asia, the Americas, Africa, and Oceania [5]. The company partnered with known global brands like USA’s Nu Skin, Denmark’s Orifarm, Canada’s Pharmascience, Israel’s Teva Pharmaceuticals, and more.

As for the company’s accreditations, there is no information available on the company’s website. Since the company has expanded its reach to a number of countries in the world and lasted very long, it can be somehow assumed that it is also well-accredited by some of the drug regulating agencies.

Scientific Studies on Isotretinoin Gel

Although the oral Isotretinoin version of the active ingredient is very effective in treating acne of increased severity, the case of the topical Isotretinoin is not the same. The effectiveness of the topical Isotretinoin treatment (gels or creams) is comparable to Tretinoin and other topical treatments for mild to moderate acne. One of the studies which evaluated the effectiveness of topical medications for the mild to moderate acne cases is the 1992 study by Hughes et al “A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne” [6]. The study compared the effectiveness of Isotretinoin gel (0.05%), benzoyl peroxide (5%) and placebo in patients with acne [6]. Isotretinoin and benzoyl peroxide both had pronounced effects in the reduction of the lesions in the 77 patients than placebo, although the effect of benzoyl peroxide was faster (4 weeks) while Isotretinoin took about 8 weeks to significantly reduce the lesions [6]. Both drugs, however, caused irritant dermatitis in some of the patients although the condition was tolerated by the patients [6]. Although both effective, the study determined that Isotretinoin acts only on the prevention of the comedone formation while benzoyl peroxide acts on both comedone formation and the inflammation [6].

Aside from its application in the management of mild to moderate cases of acne, there are also other applications discovered for topical Isotretinoin. A case study by Toros et al “Bilateral nipple hyperkeratosis treated successfully with topical isotretinoin” presented the use of Isotretinoin in the improvement of a 22-year-old’s case of bilateral nipple thickening and hyperpigmentation with no oral contraceptive use or history of pregnancy [7]. Topical Isotretinoin (0.025%) was applied to the area twice daily and within 4 weeks, the lesions disappeared but also reappeared after 4 months post therapy [7]. The same condition was managed by Isotretinoin in two weeks [7]. The study of Burge and Buxton in 1995, on the other hand, tested the application of Isotretinoin in Darier’s disease (“Topical isotretinoin in Darier’s disease”) [8]. The authors used 0.05% Isotretinoin gel on a skin patch of 11 patients with the disease and it was observed that hyperkeratosis and papules showed improvements in 3 months (6 patients) [8]. There were 3 patients who experienced adverse effects like redness, irritation, and burning sensation and 1 of those patients discontinued treatment due to the side effects [8]. It is recommended that systemic retinoids are the ones to be used for more severe cases of Darier’s disease, although it’s said that the milder cases may be managed with topical retinoids like Isotretinoin [8].

Description and Mechanism of Action of Isotretinoin

Systemic (oral) Isotretinoin works by its inhibition of the production of sebum in the patients which leads to the eventual decrease of acne lesions and bacterial presence in the skin, which are both highly influenced by sebum production on the skin.

On the other hand, the topical Isotretinoin works only on the surface of the skin by accelerating the shredding of the corneocytes on the skin [2]. This action leads to mature comedone expulsion from the skin and the prevention of new comedone production [2]. Isotretinoin also locally reverses the abnormal cell differentiation by enhancing the epithelial turnover (follicular) [2]. For this reason, topical retinoids like Isotretinoin and Tretinoin are also considered for other applications like the reversal of skin aging in patients.

Tretin Effects for Acne/Scars

The main benefits of Isotretinoin use have always been for acne. Either topical or oral, Isotretinoin is able to rid the skin of acne after a single course (or multiple courses) of treatment. Before and after results testify of the effectiveness of Isotretinoin medications for mild to severe acne, especially after the completion of the prescribed treatment.

Aside from its application for acne clearing, Isotretinoin also is used in other conditions like Darier’s disease [8] and improvement of bilateral nipple keratosis [7]. Since Isotretinoin (topical) encourages the shedding of old cells from the skin to expel comedones and encourages new epithelial turnover, it is also being used in the reversal of aging signs of the skin like wrinkles and fine lines. It is also used in the improvement the appearance of scars and stretch marks by dermatologists, although these applications for Isotretinoin’s cosmetic use have not been approved just yet.

Recommended Doses and Duration of Therapy

In topical Isotretinoin, the patients are always asked to use the lowest dose first (0.025%) before proceeding to the stronger strength. But depending on the condition and the advice of the dermatologists, patients are also prescribed the 0.05% version. The product is applied on the affected area twice a day after washing.

The results take about 3 months to show and the treatment stops when complete clearing is achieved for the skin. In some cases of relapse, the patients are prescribed another round of topical treatment. If the patients do not respond well to the initial therapy, they may be prescribed higher doses of Isotretinoin or they may be recommended to take the oral Isotretinoin version later on.

Side effects and Warnings

Since topical Isotretinoin is unlike the systemic oral type which affects even the enzyme, lipid, and blood cell levels, the side effects of the topical Isotretinoin are more localized in nature. Common reports of side effects include redness, itching, burning, stinging, and localized skin pain. In some patients, side effects of localized dryness and scaling are also observed.

Although Isotretinoin in the topical version is not systemic, patients who are pregnant are still prevented from taking the medication due to Isotretinoin’s teratogenicity (it belongs to pregnancy category X). Much caution should also be observed by female patients of childbearing age who are prescribed with the drug due to the possible harm that the drug can bring.

Drug Interactions

Topical Isotretinoin is not recommended to be used along with other retinoid treatments or other topical acne preparations like benzoyl peroxide, adapalene, and erythromycin preparations. Instead of treating the acne, the interaction between Isotretinoin and these meds may just increase the incidence of side effects. The same can be said of Vitamin A medications; since vitamin A-containing medications are of the same family as Isotretinoin, these meds when taken with Isotretinoin can increase the incidence of side effects.

Aside from these meds, antibiotic treatments should also be avoided, as well as corticosteroids like progesterone, as they may hinder Isotretinoin effect. As a general rule, patients should be open with their GPs regarding all the meds they are taking so that drug-related adverse interactions may be prevented.

Customer Reviews

Tretin gel did not have its own consumer reviews from the patients who were prescribed the drug. Reviews are important for other patients to see whether the drug is effective in the treatment of the condition it is intended, as though generic drugs contain the same active ingredients as the brand-name ones, there are some variations on the reactions these drugs elicit from the patients they were prescribed to.

Having no reviews does not mean that Tretin 0.05/0.025 gel is not as effective as the others, but can indicate the drug’s popularity. Tretin may not be as popular as the other topical Isotretinoin medications, thus the apparent lack of reviews. There is no news of the discontinuation of the drug, so the lack of reviews may just be attributed to its unpopularity and its distribution restrictions.

Price, Available Forms, and Dosage

Although the drug Tretin 0.05/0.025 gel did not have reviews online, it is sold in some online pharmacies. According to one source, Galinos.gr, the product costs $2.58 to $4.24. The lowest price is for hospital clients and the highest price is for retail buyers. Discounts are also given to online clients on wholesale purchases. Overall, the drug seems affordable even for retail buyers.

Tretin Cost

Even if the product is sold online, there is no information for international shipping of Tretin to the USA, Canada, and Australia. Although the company PNG Gerolymatos Medical S.A. is known to export to a number of countries, it seems that the product, Tretin, has not yet been cleared for international online sale. But since the presence of the company distributing the product is in about 50 countries, Tretin may be available in local drugstores where the company is allowed to export its products to.

Conclusion and Rating

There is not much information for the product Tretin 0.05/0.025 gel due to the lack of online customer reviews. The studies in the past few years regarding topical Isotretinoin products are confirming their effectiveness in the treatment of mild to moderate acne conditions. Topical Isotretinoin products like Tretin are useful in the management of less severe acne conditions and the side effects are more manageable than the systemic oral Isotretinoin version.

With regards to my rating, I am still giving Tretin 3 out of 5 since Isotretinoin effect on mild to moderate acne and even some of the other dermatologic cases are determined “good” by the studies conducted on the product from the past years. I am recommending the use of the product in patients who were prescribed with the product, and in instances where the product is readily available for sale. Compared to the oral version, the topical Isotretinoin imposes less risk, as the effects of the product are only external and localized. Plus, the product is sold affordably and is favorable for client purchase.